Ex-Cas­ca­di­an chief Scott My­ers lands at Bio­Clin; Ko­di­ak woos Genen­tech vet Ja­son Ehrlich for CMO role

Scott My­ers

Scott My­ers and Julie East­land, two of the top ex­ecs head­ed out as Cas­ca­di­an Ther­a­peu­tics got ab­sorbed in­to Seat­tle Ge­net­ics, have both set­tled at Bio­Clin Ther­a­peu­tics. Stay­ing in fa­mil­iar roles, My­ers has been named CEO while East­land is CFO and chief busi­ness of­fi­cer. My­ers, who pre­vi­ous­ly held man­age­ment po­si­tions at UCB and J&J be­fore tak­ing the helm of a med­ical de­vice com­pa­ny, suc­ceeds Bio­Clin founder Stephen Lau. The ap­point­ments are an­nounced as the San Le­an­dro, CA-based biotech is gear­ing up for reg­is­tra­tional tri­als of its lead com­pound, vo­fa­tam­ab (B-701).

→ De­gen­er­a­tive dis­ease spe­cial­ist Bi­o­Time $BTX has tapped Bri­an Cul­ley as its new CEO, tak­ing up a role pre­vi­ous­ly shared by Adi Mo­han­ty and Michael West. Cul­ley helmed Mast Ther­a­peu­tics for sev­en years be­fore a failed lead pro­gram dragged it down and left it with lit­tle op­tion oth­er than serv­ing as a shell for Savara’s re­verse merg­er. West will now move on­to the chief ex­ec­u­tive role at AgeX, a Bi­o­Time af­fil­i­ate fo­cused on age-re­lat­ed de­gen­er­a­tive ail­ments.

Vanes­sa King

→ Ex­pe­ri­enced biotech vet Vanes­sa King has tak­en the CEO job at Lon­don-based Viri­on Bio­ther­a­peu­tics, build­ing on a par­ti­cle tech plat­form to fo­cus on res­pi­ra­to­ry dis­ease. King had been CEO at Luc Ther­a­peu­tics and ear­li­er worked the busi­ness de­vel­op­ment side of the ta­ble for de­CODE, be­fore Am­gen bought out the com­pa­ny. Is­abel Na­jera was al­so named as the com­pa­ny’s chief sci­en­tif­ic of­fi­cer.

→ Por­to­la $PT­LA has turned to an ex­pe­ri­enced com­mer­cial ex­ec for its new CEO. Scott Gar­land is join­ing the com­pa­ny from Re­lyp­sa, where he was pres­i­dent. Ear­li­er Gar­land had been an EVP at Ex­elix­is and has a re­sume that in­cludes a stint at Genen­tech.

→ Just days af­ter map­ping out a com­pet­i­tive strat­e­gy for its oph­thal­mol­o­gy drug in a $100 mil­lion IPO fil­ing, Ko­di­ak Sci­ences says it’s brought in Genen­tech vet Ja­son Ehrlich as chief med­ical and de­vel­op­ment of­fi­cer. As glob­al head of clin­i­cal oph­thal­mol­o­gy at the big biotech, Ehrlich was a lead clin­i­cian for Lu­cen­tis — one of the cur­rent an­ti-VEGF drugs that Ko­di­ak has set out to beat. Al­so new to the com­pa­ny are Al­mas Qudrat, VP of qual­i­ty op­er­a­tions, and Pablo Ve­lazquez-Mar­tin, who will over­see clin­i­cal re­search and trans­la­tion­al med­i­cine.

Wladimir (Vlad) Hogen­huis is the new — and first — chief op­er­at­ing of­fi­cer at Ul­tragenyx $RARE, join­ing a team that’s ea­ger to re­al­ize block­buster am­bi­tions for its grow­ing port­fo­lio of rare dis­ease drugs. A long­time Mer­ck ex­ec, Hogen­huis spent the last six years at Glax­o­SmithK­line in a range of com­mer­cial and op­er­a­tional ca­pac­i­ties. That kind of all-round­ed ex­per­tise, Ul­tragenyx CEO Emil Kakkis says, will serve the com­pa­ny well for “many years to come.”

Jared Gol­lob

→ Fresh off the his­toric ap­provals of Al­ny­lam’s first RNAi drug, long­time staffer Jared Gol­lob has jumped ship to pur­sue an­oth­er “new fron­tier in drug dis­cov­ery” — pro­tein degra­da­tion. As CMO at Cam­bridge, MA-based Kymera, Gol­lob is tasked with ad­vanc­ing prod­uct can­di­dates for can­cer, au­toim­mune and in­flam­ma­to­ry dis­eases iden­ti­fied by the com­pa­ny’s plat­form, all of which are still in the pre­clin­i­cal stage.

Na­tal­ie Sacks is part­ing ways with Aduro Biotech $ADRO af­ter serv­ing as its chief med­ical of­fi­cer for two years. Sacks’ tenure at the can­cer im­munother­a­py com­pa­ny was marked by a rocky clin­i­cal jour­ney with the can­cer vac­cine CRS-207, which lived through a par­tial hold but was ul­ti­mate­ly scrapped for dis­ap­point­ing ef­fi­ca­cy. There’s no im­me­di­ate word on Sacks’ next steps af­ter she of­fi­cial­ly leaves on Oc­to­ber 1.

Melin­ta Ther­a­peu­tics $ML­NT has ap­point­ed Pe­ter Mil­li­gan as the suc­ces­sor to CFO Paul Es­trem, who is re­tir­ing af­ter lead­ing the an­tibi­otics biotech through the re­verse merg­er with Cem­pra and the ac­qui­si­tion of The Med­i­cines Com­pa­ny’s in­fec­tious dis­ease unit. Mil­li­gan joins from gener­ics phar­ma G&W Lab­o­ra­to­ries, where he had the same role.

Ja­cob Chacko has re­cruit­ed a for­mer Igny­ta col­league to his team at Oric Phar­ma. Pratik Mul­tani, who used to be CMO of the Roche-ac­quired biotech, will as­sume the same po­si­tion in Oric and im­me­di­ate be­gin steer­ing lead drug ORIC-101 in­to the clin­ic. “De­spite many new ther­a­pies, re­sis­tance re­mains a sig­nif­i­cant bar­ri­er to im­proved out­comes in most pa­tients with ad­vanced can­cers, and ORIC is at the fore­front of work to ad­dress that chal­lenge, be­gin­ning with the glu­co­cor­ti­coid re­cep­tor an­tag­o­nist and con­tin­u­ing with the rest of the pipeline,” he said in a state­ment.

→ Fol­low­ing a stint as head of biotech in­vest­ment bank­ing at RBC Cap­i­tal Mar­kets, Shane Ko­vacs is back in the front lines of biotech as chief busi­ness and fi­nan­cial of­fi­cer of Blue­Rock Ther­a­peu­tics. This would mark his sec­ond for­ay in­to biotech since leav­ing Cred­it Su­isse in 2013, the first be­ing at PTC Ther­a­peu­tics. Found­ed by Ver­sant Ven­tures and backed by Bay­er, Blue­Rock is de­vel­op­ing cell ther­a­pies for re­gen­er­a­tive use.

Am­gen vet and for­mer Kite Phar­ma ex­ec An­tho­ny Polveri­no has joined Zymeworks $ZYME as CSO and EVP of ear­ly de­vel­op­ment, tak­ing a cen­tral role in dri­ving the R&D strat­e­gy for an am­bi­tious team de­vel­op­ing “mul­ti­func­tion­al ther­a­peu­tics”.

No­var­tis spin­out resTOR­bio $TORC has hired sea­soned com­mer­cial ex­ec Mered­ith Man­ning as chief com­mer­cial of­fi­cer. Hav­ing worked in mar­ket­ing, prod­uct de­vel­op­ment and oth­er strate­gic roles across Pfiz­er, Ver­tex, Bax­ter and Shire, she is now ex­pect­ed to pave a way for resTOR­bio’s an­ti-ag­ing ther­a­pies.

Syned­gen has brought in Kaveri Park­er to lead busi­ness de­vel­op­ment and com­mer­cial­iza­tion of its gly­comics tech plat­form, which aims to treat in­flam­ma­to­ry and in­fec­tious dis­eases by tar­get­ing mu­cos­al in­ter­faces. The new chief busi­ness of­fi­cer was most re­cent­ly pres­i­dent and CEO of a di­ag­nos­tics com­pa­ny called ID Ge­nomics.

→ MPM-backed Har­poon Ther­a­peu­tics has tapped Chris Whit­more, alum­ni of an­oth­er im­muno-on­col­o­gy com­pa­ny called Im­mune De­sign, as VP of fi­nance. Con­cur­rent­ly, Seat­tle Ge­net­ics’ for­mer CMO Jonathan Drach­man has joined their board.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.